Iatrogenic disease, illness caused by treatment by a physician, is the third leading cause of death in the U.S. following heart disease and cancer, respectively. Conservative estimates indicate that over 250,000 people die every year in the U.S. due to iatrogenic disease. The high incidence of iatrogenic disease in the U.S. is a result, in part, of the inadequacy of effective tools for surgical training and training of medical personnel entering the workforce. As a result, residents are released from residency with inadequate experience and are not prepared for entering the physician workforce. These findings are demonstrated by the lack of general surgeons in the physician workforce and the excessive adverse events in surgery that result in disability and/or death. The population continues to grow steadily yet the current supply of general surgeons do not meet the demand. With projected aging population and increased healthcare needs, the supply is also likely unable to meet the demands of 2025. Population projections are expected to continue to increase by 1% every year. Unfortunately, over the last 25 years the number of general surgeons has been steadily decreasing about 1% every year for a total of 26% less general surgeons between 1981 and 2005 (Lynge D C, et al. “A longitudinal analysis of the general surgery workforce in the United States, 1981-2005.” Arch Surg 2008; 143:345-50.).
Surgical adverse events have several associated costs including: economic loss, malpractice lawsuits against health care systems, community and patient trust in those health care systems, decreased satisfaction for both health care providers and patients. According to a 2013 Institute of Medicine report (Best Care at Lower Cost: The Path to Continuously Learning in America), an estimated $2.6 trillion is spent in healthcare annually. Unfortunately, $750 billion of that is spent on inefficient and wasteful healthcare. In other words, one-third of health care expenditures are wasted. Extrapolating for the 60% of medical errors that occur in the operating room, $450 billion is lost annually due to operative errors.
In general, 60% of all adverse events are attributed to surgical errors (E. de Vries, et. al. “The incidence and nature of in-hospital adverse events: a systematic review.” Qual Saf Health Care, 2008; 17(3): 216-223.). Specifically, the causes of errors include poor surgical technique (33%), inattention to detail (15%), judgement error (12%) and an incomplete understanding of the procedure (12%) (P. J. Fabri, J. L. Zayas-Castro. “Human error, not communication and systems, underlies surgical complications.” Surgery, 2008; 144: 557-563.). All of these errors occurring during surgery are preventable and, at least in part, are due to the inability of residents to practice and receive feedback on their surgical technique before operating on patients.
Due to the lack of adequate preparation in general surgery residency, a dearth of general surgeons has been created due to the increase in popularity of surgical subspecialization. Over 80% of general surgery residents choose to join fellowship programs following residency (Jancin B. “Surgical fellowship directors: General surgery trainees arrive ill prepared.” The Oncology Report. May 1, 2013.). Further, investigations have revealed that 25% of senior surgery residents feel inadequately prepared for independent practice (Bucholz E M, et al. “Our trainees' confidence: Results from a national survey of 4136 U.S. general surgery residents.” Arch Surg. 2011; 146(8):907-914.).
Current systems and methods of training general surgeons include animal and cadaver surgeries as well as other simulators (Beyer-Berjot L, et al. “Advanced training in laparoscopic abdominal surgery: a systematic review.” Surgery, 2014; 156(3):676-88; Sharma M, et al. “Basic laparoscopic skills training using fresh frozen cadaver: a randomized controlled trial.” Am J Surg, 2013; 206(1):23-31.). While currently available systems and methods do simulate operations or procedures to varying degrees, these surgical simulators are lacking in several areas. For example, the materials used in current products are not compatible with electrosurgical instruments and lack adequate tactile sensation and anatomy. Currently available products do not allow for practice of modern laparoscopic procedures with electrosurgical tools because the materials are not compatible with the electrosurgical instruments. The materials in currently available products either cannot be safely used with electrosurgical instruments or do not give the proper response when energy is applied to the materials. Further for example, the anatomy of the currently available products differs as compared to human anatomy. In many cases, the shape, color, and/or size of the synthetic tissues or anatomy is not realistic or true to analogous human tissues. Additionally, many currently available products do not have connective tissues to house vessels. In fact, many of the abdominal organs available do not even include an integrated vascular system. A method of physically connecting each of the organs and tissues to one another is imperative to simulating a surgical procedure.
Better training tools are needed to adequately prepare future general surgeons and increase the chance that surgeons remain in general practice to meet supply needs. Current approaches limit the quality and functionality of a simulator for abdominal surgeries, a common procedure for general surgeons, because they lack the innovative modular approach to solving the problem. Each area of the body includes many different types of tissues that are physically connected to one another; this is not seen in current products. Thus, the current landscape of abdominal surgical simulation products lacks innovative materials and integration of those materials to one another. More sophisticated simulation tools are desperately needed to appropriately address these issues.